MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS NEEDLE 1/2 CIRCLE MAYO CATGUT .050X.984 STERILE; NEEDLE, SUTURING, DISPOSABLE

Model Number 216706

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from swissmedic indicating that a surgical needle broke during a procedure.The actual device is in process of being returned for evaluation.The manufacturing lot number was provided for review.Photographic evidence was provided for review as well.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from swissmedic indicating that a needle broke during a procedure.Incident occurred at the end user.The needle is needed to fix the port.The needle broke off during the fixation of the port.The needle was found immediately.No injury was reported.

• Brand Name: NEEDLE 1/2 CIRCLE MAYO CATGUT .050X.984 STERILE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: terry hall ; 6945 southbelt dr; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 18218088
• MDR Text Key: 329138372
• Report Number: 1836161-2023-00042
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 216706
• Device Lot Number: 329254
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female